FDA Launches TEMPO Digital Health Pilot
The U.S. Food and Drug Administration announced the new Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health…
FDA introduces TEMPO model to complement CMS ACCESS model
The Food and Drug Administration plans to select about 40 devices not yet cleared by the agency to receive special agency discretion to participate in the new chronic care Advancing…